ZIMIEX TABLET 10mg

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

EZETIMIBE

Предлага се от:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Международно Name):

EZETIMIBE

Броя в опаковка:

3x10 Tablets; 10x10 Tablets

Произведено от:

Watson Pharma Private Limited

Листовка

_ Consumer Medication Information Leaflet (RiMUP)_
ZIMIEX TABLET 10MG_ _
Ezetimibe (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What ZIMIEX is used for
2.
How ZIMIEX work
3.
Before you use ZIMIEX
4.
How to take ZIMIEX
5.
While
you
are
using
ZIMIEX
6.
Side Effects
7.
Storage
and
Disposal
of
ZIMIEX
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT
ZIMIEX IS USED FOR
ZIMIEX is a tablet that contains
10 mg of ezetimibe as the active
ingredient.
Ezetimibe
is
a
cholesterol-
lowering medicine. It is used
for
patients
whose
cholesterol
levels are too high and
when
diet
alone
cannot
lower
these
levels adequately.
Ezetimibe
reduces
elevated
total-cholesterol,
LDL
(bad)
cholesterol and triglycerides and
increases
HDL
(good)
cholesterol. It may be taken
with other cholesterol-lowering
medicines known as statins or
alone, in addition to diet.
Ezetimibe
may
be
taken
with
fenofibrate, another cholesterol-
lowering medicine, in addition
to diet.
HOW
ZIMIEX WORK
ZIMIEX
works
by
decreasing
the absorption of cholesterol in
the small intestine. Statins and
fenofibrate
works
in
different
ways to lower cholesterol in the
liver. It adds to the cholesterol-
lowering
effect
of
statins
and
fenofibrate.
BEFORE YOU USE ZIMIEX
_-When you must not take it _
Do not take ZIMIEX if you:
•
are allergic to ezetimibe and
any of its ingredients
•
are
pregnant
or
nursing
a
baby
•
have
active
liver
problems
or unexplained elevations in
some laboratory blood tests
of liver function
If you think any of these are
relevant to you, do not take the
tablets until you have consulted
your doctor.
_-Before you start to take it _
Tell your doctor or pharmacist
if you:
•
have any medical problems
(including
liver
disease
or
liver problems) or allergies
you have now or have had in
the past.
•
plan to become pregnant as
ezetimibe may not be right
for you.
Pregnancy and breast-feeding:
It
is
not
known
whether
ezetimibe can harm the baby if
it is used during pregnancy. If
you
are
pregnant
or
plan
to
be

Данни за продукта

5
18.12.2020
MT
06.01.2022
MT
190x600 mm
Actavis Bulgaria Dupnitsa
10
04.01.2021
1.
2.
3.
1. black
2.
3.
4.
5.
6.
AAAM8064 - Ezetimibe 10 mg -, PIL, Malaysia
DESCRIPTION
White to off white capsule shaped tablets debossed with “713”
on one side and plain on the other side.
Dimension: About 8 mm x 4 mm
COMPOSITION
Each tablet contains 10mg ezetimibe.
PHARMACOLOGY
Pharmacotherapeutic group: Other lipid modifying agents. ATC
code: C10A X09
Ezetimibe is orally active, and has a mechanism of action that
differs from other classes of cholesterol-reducing compounds
(e.g. statins, bile acid sequestrants [resins], fibric acid
derivatives,
and plant stanols). The molecular target of ezetimibe is the
sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which
is responsible for the intestinal uptake of cholesterol and
phytosterols. Ezetimibe localises at the brush border of the small
intestine and inhibits the absorption of cholesterol, leading to a
decrease in the delivery of intestinal cholesterol to the liver. This
causes a reduction in hepatic cholesterol stores and an increase
in clearance of cholesterol from the blood. Ezetimibe does not
increase bile acid excretion (like bile acid sequestrants) and does
not inhibit cholesterol synthesis in the liver (like statins).
By inhibiting the absorption of intestinal cholesterol, ezetimibe
reduces the delivery of cholesterol to the liver. Statins reduce
cholesterol synthesis in the liver. Together these distinct
mechanisms provide complementary cholesterol reduction.
Ezetimibe, administered with a statin, reduces total-C,
LDL-C, Apo B and TG and increases HDL-C in patients with
hypercholesterolemia, beyond either treatment alone.
Administration of ezetimibe with fenofibrate is effective in
improving serum total-C, LDL-C, Apo B, TG, HDL-C, and non-HDL-C
in patients with mixed hyperlipidemia.
PHARMACOKINETICS
_ABSORPTION:_ After oral administration, ezetimibe is rapidly
absorbed and extensively conjugated to a pharmacologically
active phenolic glucuronide (ezetimibe glucuronid